Nuports Inc. – FDA Warning Letter

The FDA Center for Tobacco Products issued a Warning Letter to Nuports.com after reviewing their website and determining that their e-liquid products, specifically "Juicy Melon e-liquid," are tobacco products subject to FDA jurisdiction. The primary violation identified was the sale of "Juicy Melon e-liquid" to a person younger than 18 years of age, which was revealed during an FDA investigation. This action constitutes a misbranding violation under section 903(a)(7)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 387c(a)(7)(B)) because it violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products to minors. The letter emphasizes that the firm must immediately correct this violation and similar issues, ensuring all tobacco products, labeling, and advertising on their website and other media comply with the FD&C Act and FDA regulations. Nuports.com is required to submit a written response within 15 working days detailing corrective actions, including dates of discontinuing violative sales and a plan for sustained compliance. Failure to comply could lead to severe consequences, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and detention of imported products.